Monthly Archives: April 2017

European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy

Source: pipelinereview.com
Author: Bristol-Myers Squibb

Bristol-Myers Squibb Company today announced that the European Commission (EC) has approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology (I-O) treatment that demonstrated in a Phase 3 trial a significant improvement in overall survival (OS) for these patients.

“Adult patients with squamous cell cancer of the head and neck that progresses on or after platinum-based therapy are fighting a debilitating and hard-to-treat disease that is associated with a very poor prognosis,” said Kevin Harrington, M.D., Ph.D., professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust in London. “As an oncologist who helps patients deal with this terrible disease, I hope that nivolumab will now be made available as widely as possible, offering this group of patients a new treatment option that can potentially improve their overall survival.”

The approval was based on results from CheckMate -141, a global Phase 3, open-label, randomized trial, first published in The New England Journal of Medicine last October, which evaluated Opdivo versus investigator’s choice of therapy in patients aged 18 years and above with recurrent or metastatic, platinum-refractory SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary or metastatic setting. Investigator’s choice of therapy included methotrexate, docetaxel, or cetuximab. The primary endpoint was OS. The trial’s secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).

“The European Commission’s approval of Opdivo marks not only the first new treatment option in 10 years for patients with advanced cancers of the head and neck, but also the first Immuno-Oncology treatment for SCCHN,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Bristol-Myers Squibb remains committed to redefining survival for patients with cancer, and now that Opdivo is approved in Europe, we will work collaboratively with EU health authorities to ensure it is available for these patients as quickly as possible.”

In the interim analysis of the pivotal trial, Opdivo demonstrated statistically significant improvement in OS with a 30% reduction in the risk of death (HR=0.70 [95% CI: 0.53-0.92; p=0.0101]), and a median OS of 7.5 months (95% CI: 5.5-9.1) for Opdivo compared with 5.1 months (95% CI: 4.0-6.0) for the investigator’s choice arm. There were no statistically significant differences between the two arms for PFS (HR=0.89; 95% CI: 0.70, 1.13) or ORR (13.3% [95% CI: 9.3, 18.3] vs 5.8% [95% CI: 2.4, 11.6] for Opdivo and investigator’s choice, respectively. The EC approval was based on updated study results, which will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO).

Patient reported outcomes (PROs) were evaluated using the following European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Assessment: EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D instruments. Patients treated with Opdivo exhibited stable PROs, while those assigned to investigator’s choice therapy exhibited significant declines in functioning (e.g., physical, role, social) and health status as well as increased symptomatology (e.g., fatigue, dyspnoea, appetite loss, pain and sensory problems).

The safety profile of Opdivo in CheckMate -141 was consistent with prior studies in patients with melanoma and non-small cell lung cancer. Serious adverse reactions occurred in 49% of patients receiving Opdivo. The most frequent serious adverse reactions reported in at least 2% of patients receiving Opdivo were pneumonia, dyspnea, aspiration pneumonia, respiratory failure, respiratory tract infection, and sepsis.

About Head & Neck Cancer
Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell cancer of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. Human Papilloma Virus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America.

About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U. S. FDA approved indications for Opdivo
Opdivo® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Opdivo® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Opdivo® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Opdivo® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Opdivo® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Opdivo® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Opdivo® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Opdivo® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

April, 2017|Oral Cancer News|

‘Happy Days’ star Erin Moran’s Husband Reveals Tragic Details about Cancer

Author: Marah Alindogan
Source: www.aol.com
Date: Apr 25th 2017

Erin Moran’s husband, Steve Fleischmann, revealed heartbreaking details about the months leading up to her death in a Facebook post on Tuesday.

New evidence from the Harrison County Sheriff’s Office on Monday suggested that the actress likely died due to complications from stage 4 cancer. The open letter, which was posted on Scott Baio’s official Facebook page, confirmed the report.

“Erin and I met 4/22/1992 and parted ways 4/22/2017,” her husband began the letter.

He recalled that Erin “woke up and had about a dime size blood stain on her pillowcase” right after they got back from a trip to celebrate their wedding anniversary in November of last year. After a couple of days, they kept on finding more blood.

“I get a flashlight and say let me look. It was not her tongue it was her tonsil on the left side. I thought it was tonsillitis,” wrote Fleischmann.

After getting a biopsy, doctors confirmed she had squamous cell carcinoma — a common form of cancer. Shortly after, she started radiation and chemo — five days a week on radiation and chemo only on Thursdays.

However, Erin’s condition slowly deteriorated: “It got so bad so fast. By the middle of February, Erin could no longer speak or eat or drink.”

Despite her poor health, the actress remained in good spirits.

“She was still happy, she was active, she texted people on her phone all day,” Steve added.

The day before her death, April 21, she had trouble breathing. And the next day, Steve claimed she wasn’t 100 percent.

“I laid down next to her held her right hand in my left. I feel asleep woke up about a hour later still holding her hand and she was gone, she was just gone …”

Steve revealed Norton Cancer Institute, where his wife received treatments, “never said how bad it was.”

“The coroner told me it was really really bad. It had spread to her spleen, she had alot of fluid in her lungs and part of her brain was infected,” he shared. “The coroner said even if she was in the hospital being pumped full of antibiotics she still would not of made it. He said it was the best that she was with me and went in her sleep.”

April, 2017|Oral Cancer News|

Overwhelming support from GPs & dentists for boys to receive the HPV vaccination

Date: 4/24/2017
Source: http://www.hpvaction.org

  • 97% of dentists and 94% of GPs would have their own sons vaccinated against the Human Papillomavirus (HPV), in a new survey published ahead of World Immunisation Week 24th-28th April.
  • 97% of dentists and 94% of GPs believe that the national HPV vaccination programme should cover both boys and girls.

95% of GPs and dentists together said if they had a son they would want him to receive the HPV vaccination. The findings come as the Government’s vaccination advisory committee (JCVI) moves towards a decision on whether boys should be given the HPV vaccination.

BRITISH MEDICAL ASSOCIATION

Dr Andrew Green, a member of the BMA’s General Practitioners Committee (GPC), said: “If we want to see an end to some of the most aggressive and hard to treat cancers such as throat, head, neck and anal cancer, boys as well as girls must be given the HPV vaccination. It is ridiculous that people are still dying from these cancers when their life could have easily been saved by a simple injection.”

BRITISH DENTAL ASSOCIATION

Mick Armstrong, Chair of the BDA’s Principal Executive Committee, said: “HPV is the leading cause of oro-pharyngeal cancers and men are just as likely to develop it as women so where is the logic – or fairness – in targeting protection to one section of the population? It is morally indefensible to allow people to contract cancer when prevention – the new NHS mantra – could be so cheap and easy. Cancers affecting the mouth and throat have a huge impact on the quality of people’s lives, so it’s frustrating for dentists, who are often the first to detect them, knowing how easily they could have been prevented.”

LETTER TO JEREMY HUNT

Parliamentarians from all parties have signed an open letter to the Health Secretary, Jeremy Hunt MP, urging him to ensure that the UK doesn’t miss this opportunity to eradicate some of the fastest rising cancers in the developed world.
Up to 80% of sexually active people will be infected by HPV at some point in their lives. 5% of all cancers are caused by HPV and some of these, notably oral cancers, are now rising sharply in incidence. HPV-related cancers such as anal cancer are also among the hardest to diagnose and treat.

THE COST-EFFECTIVE ARGUMENT

Many doctors, dentists, scientists and professional and patient organisations who support the vaccination of both sexes are concerned that the JCVI will reject universal coverage on the grounds of cost despite the vaccination’s ability to protect against 5% of all cancers and the huge cost of treating HPV-related cancers and other diseases caused by HPV (genital warts and recurrent respiratory papillomatosis).

It is estimated that vaccinating boys would cost £20-22m a year at most – a figure that is dwarfed by the cost of treating HPV-related cancers and warts. An estimated £57.1 million is spent treating head and neck cancer (in England), almost £7 million on treating men with anal cancer and an estimated £58.44 million a year treating anogenital warts.

Newly-published research by Favato G, Easton T, Vecchiato R, Noikokyris E. “Ecological validity of cost-effectiveness models of universal HPV vaccination: a systematic literature review” casts doubt on hitherto published cost-effectiveness modelling and highlights the uncertainties in the process.

The authors comment: “Our findings indicate that the selective immunisation of prepubertal girls is likely to fail to achieve the expected level of herd immunity at population level. A relatively small (15–20%) overestimation of QALY-gained with selective immunisation programmes could induce a significant error in the estimate of the cost-effectiveness of universal immunisation, making the option of vaccinating boys [wrongly appear to be] cost-ineffective.”

WHY GIRLS NOT BOYS?

As well as cost, the main argument deployed against vaccinating boys is that the girls’ programme indirectly protects boys. However, this has been widely dismissed because it fails to take into account men who have sex with unvaccinated women (from the UK and other countries) or men who have sex with men.

LEADING CAMPAIGNER 

One of the key voices in the campaign, Tristan Almada, HPV & Anal Cancer Foundation, said: “The UK government cannot ignore the overwhelming support from GPs, dentists and MPs who want boys to have the HPV vaccination. With every year that passes, almost 400,000 more boys go unvaccinated and are therefore at
risk of developing a HPV-related cancer later in life. The government must roll out gender-neutral vaccination nationally as soon as possible.”

THE GLOBAL VIEW

Australia, USA, Brazil, Bermuda, New Zealand, Austria, Israel, Italy, Switzerland and Canada all recommend that boys are vaccinated as well as girls.

HPV ACTION

Peter Baker, HPV Action Campaign Director, said: “HPV affects men and women equally and both sexes therefore deserve equal protection though a national vaccination programme. It is now time for the Government’s vaccination advisory committee to look up from its financial spreadsheets and act to end the suffering of those men and women affected by easily-preventable diseases caused by HPV.”

The survey was carried out by HPV Action with the support of the HPV and Anal Cancer Foundation and its other members. HPV Action is asking people, especially the parents of boys, to sign an online petition demanding gender-neutral vaccination: and will be calling on all political parties to commit themselves to gender-neutral HPV vaccination during the forthcoming General Election campaign.

April, 2017|Oral Cancer News|

HPV vaccine; cancer prevention

Source: www.nujournal.com
Author: staff

Human papillomavirus (HPV) is a sexually transmitted infection, of several strains, most associated with cervical cancers. The virus is so common that nearly all males and females have been infected at some time in their life. One in four is currently infected in the nation.

Signs and symptoms of HPV are variable. Most will recover from the virus within two years without ever knowing they were infected, making HPV easy to spread. Occasionally, the virus lasts much longer in the body which can cause cells to change and lead to cancer. Fortunately, we have a vaccine to prevent cancer caused by HPV.

The Food and Drug Administration (FDA) has approved three vaccines for HPV; Cervarix, Gardasil, and Gardasil 9. These vaccines are tested and proven to be safe and effective.

Prevention is important with HPV. The vaccine should be administered before exposure to the virus for stronger protection against cervical, vaginal, vulvar, penile, and some mouth or throat cancers. (Gardasil and Gardasil 9 also prevent genital warts and anal cancer.) The best age to obtain maximum potential of the vaccine is at 11 or 12 years old. At this age, the body’s immune system is the most receptive to the vaccination’s virus-like particles and the body produces higher amounts of antibodies in defense, protecting the adolescent for his or her future. Both girls and boys should get the HPV vaccine. For ages 9-14, two doses – six to twelve months apart, are recommended. For 15-26 year olds, three doses are recommended. Side effects may include brief soreness, or redness or swelling at the injection site.

The HPV vaccine does prevent cancer, limiting biopsies and invasive procedures thus cutting potential health care costs. Most private insurance companies cover preventive vaccinations, it is best to call your carrier for more information. The HPV vaccine is covered by Minnesota Health Plans. Uninsured individuals may be eligible to get the vaccine at their local public health office.

Schedule your adolescent’s annual health exam today and ask which HPV vaccine is best for the child in your life.

“Every year in the United States, HPV causes 30,700 cancers in men and women. HPV vaccination can prevent most of the cancers (about 28,000) from occurring.” (CDC, December, 2016)

Learn more at www.cdc.gov/hpv or www.cancer.gov

April, 2017|Oral Cancer News|

Beating HPV-positive throat cancer

Source: www.huffingtonpost.com
Author: Pamela Tom, Contributor

National Oral, Head, and Neck Cancer Awareness Week is April 12-18, 2017

For at least two years, 47 year-old Rob Clinton of Rochester, NY, would choke on post nasal drip in the shower. He knew something was wrong in his throat but he didn’t feel any pain.

Did he have cancer? Clinton smoked cigarettes for 30 years and worked in an auto body shop where he was regularly exposed to carcinogens, but he wasn’t experiencing the typical symptoms of throat cancer. These include hoarseness or a change in the voice, difficulty swallowing, a persistent sore throat, ear pain, a lump in the neck, cough, breathing problems, and unexplained weight loss.

In November 2015, Clinton went to the dentist to have his teeth cleaned. His dentist felt Clinton’s swollen neck and recommended that he visit a medical doctor. Clinton heeded the advice and sought the opinion of an ear, nose, and throat specialist at Strong Memorial Hospital in Rochester, NY.

The ENT doctor sent Clinton to have a CAT scan and when he scoped Clinton’s throat, the doctor said, “I see something in there.”

What he saw was a tumor and there were a few other things going on too.

The Diagnosis
The biopsy showed that Clinton had Stage IVa oral squamous cell carcinoma (OSCC) at the base of his tongue—and the cancer was HPV positive. HPV stands for the human papillomavirus and a recent survey found that more than 42% of Americans are infected with HPV. While most people’s bodies naturally clear HPV after two years, some people’s immune systems do not recognize the virus and consequently, HPV can harbor in the body for decades. HPV-related throat cancer has been linked to oral sex.

The Treatment
On December 4, 2015, Clinton underwent neck dissection surgery at Roswell Park Cancer Institute in Buffalo, NY. Dr. Hassan Arshad, a head and neck cancer surgeon, removed 30 lymph nodes; two had cancer and one tumor was the size of a golf ball. One lymph node on the other side of neck and a tongue tumor would be treated with radiation.

The first of 35 radiation treatments began one month later in conjunction with Cisplatin chemotherapy infusions. That’s seven weeks of simultaneous radiation and chemo.

“I drove myself to treatment for the first five weeks. Up until the last week of treatment, it wasn’t too terrible,” Clinton says. “But then I started getting tired and my mother took me to the cancer center.”

Clinton had decided not to get a feeding tube prior to or during treatment and as the radiation and chemo attacked his cancer, he began to lose weight. The treatment reduced Clinton’s appetite because foods began to taste different. For two weeks, he also felt a burning sensation in his mouth and says his saliva tasted like hot sauce.

“It was excruciating and the worst thing I dealt with during treatment.”

Furthermore when radiation makes the throat feel tender and raw, it becomes nearly impossible to eat normally through the mouth.

Clinton was 215 pounds before treatment. After treatment, he weighed in at a mere 165 pounds. A loss of 50 pounds. In hindsight, Clinton wishes he had the feeding tube inserted while he was still strong.

“Don’t be afraid of the treatment. It’s manageable and you can get through it. I recommend a feeding tube because it’s a comfort knowing you have an option,” says Clinton.

The Recovery
While it took a month for Clinton to recover from the initial surgery, doctors say it takes at least a year for HPV+ throat cancer patients to find their “new normal”—regaining strength, adapting to lingering side effects.

Following chemo, Clinton experienced “chemo brain” or “chemo fog,” known as a cognitive impairment that can occur after chemotherapy. The patient may experience memory loss or dysfunction, and have difficulty concentrating or multi-tasking.

The radiation also took its toll on Clinton. He researched and found a salve made of calendula flowers, olive oil, beeswax, and Vitamin E oil to soothe his parched skin. Trying to gain weight was a bigger challenge. First, his taste went “totally upside down” and spicy foods were intolerable.

“A vanilla cookie tasted like black pepper,” Clinton says. “Only frozen peas and parsley tasted normal.”

And dry mouth is a common result of the radiation treatment. While both sides of Clinton’s neck received radiation, he had less saliva production on his left side. At night he would have to wake up every 40 minutes to drink water. Clinton must make certain not to become dehydrated because it causes the dry mouth to worsen. Now he chews gum almost non-stop.

In his search to combat dry mouth, Clinton says he researched solutions online and found ALTENS, or acupuncture-like transcutaneous electrical nerve stimulation. A study led by Dr. Raimond Wong, an associate professor of oncology at McMaster University in Ontario, Canada, found evidence that ALTENS may reduce patient-reported xerostomia, the medical term for dry mouth.

Clinton joined Dr. Wong’s clinical trial to determine whether ALTENS for six weeks/four days a week would be as effective as treatment for 12 weeks/two times a week.

“Four days a week, the researchers put pads on the inside of my ankles, the outside of my knee, back of my hands, between my thumb and forefingers, and between my chin and bottom lip,” says Clinton.

Clinton says ALTENS felt like little shocks and the acupuncture-like stimulation improved his saliva production by 80 percent. “Even after I stopped ALTENS, my saliva kept improving,” says Clinton.

The Survivor
Two years after cancer treatment, regular PET scans show that Rob Clinton has no evidence of cancer. In fact, the prognosis for HPV-related throat cancer is 85 to 90 percent positive if caught early. In contrast, patients who battle advanced throat cancer caused by excessive smoking and alcohol have a five-year survival rate of 25 to 40 percent.

Dr. Arshad, Clinton’s surgeon at the Roswell Park Cancer Institute, explained why.

“The majority of tonsil and tongue base (“throat”) cancers are HPV-positive, but smoking is still a major risk factor. Typically, non-smoking patients with HPV-positive tonsil/tongue base cancers present with a lump in the neck, implying that the cancer has already spread to lymph nodes. This used to mean that the patient would have a reduced chance of long-term survival,” Arshad says. “We now know that for nonsmokers who have HPV-positive cancers, metastasis to lymph nodes doesn’t carry the same poor prognosis. The newest staging system reflects that change, i.e. Some of those patients who were previously classified as stage IV are now at stage II if the cancer is HPV-positive.”

Clinton is not only faring well physically, surviving cancer changed his outlook and lifestyle.

“My life is pretty much back to normal. I get a little nervous each time I get a PET scan but so far, it shows I am free of cancer,” Clinton says. “I have a better appreciation of things. I live healthy in terms of diet and recreation. I don’t smoke or drink heavily.”

The Future of HPV+ Oropharyngeal Cancer
De-stigmatizing HPV is a key component to building public awareness and acceptance of HPV infection, and the ability to recognize the early symptoms of HPV-related throat cancer. As more and more people are diagnosed with HPV-related throat cancer, the social stigma surrounding the virus is a disturbing deterrent because HPV cancer patients are often reticent to disclose the HPV connection.

In a 2015 public service announcement, actor Michael Douglas who was treated HPV+ base of tongue cancer called for oral screenings but never said “HPV” by name. “A very common virus, one responsible for the vast majority of cervical cancers is now identified as the cause of this rapid rise in oral cancers,” said Douglas.

In the early years of the AIDS crisis, people associated infection with illness, fear, and death. It took a decade to generate a movement and begin to change the public sentiment. Now after continual education, AIDS is accepted and the focus centers on hope instead of ostracization.

Clinton hopes more people will accept that HPV infection is common—the most common sexually-transmitted infection in the U.S., according to the CDC. The American Society of Clinical Oncologists also found that by 2020, the annual number of HPV-related oropharyngeal in nonsmoking, middle-aged men will surpass the number of cervical cancer cases.

“HPV is not a shameful thing. It’s very common. It’s just that some people can’t clear the virus from their bodies,” Clinton says. “This type of cancer is the next epidemic. I feel fortunate every day that I came through it as well as I did.”

April, 2017|Oral Cancer News|

Close to Half of American Adults Infected With HPV, Survey Finds

Source: www.nytimes.com
Author: Nicholas Bakalar
Date: 04/06/2017

More than 42 percent of Americans between the ages of 18 and 59 are infected with genital human papillomavirus, according to the first survey to look at the prevalence of the virus in the adult population.

The report, published on Thursday by the National Center for Health Statistics, also found that certain high-risk strains of the virus infected 25.1 percent of men and 20.4 percent of women. These strains account for approximately 31,000 cases of cancer each year, other studies have shown.

Two vaccines are effective in preventing sexually transmitted HPV infection, and researchers said the new data lend urgency to the drive to have adolescents vaccinated.

“If we can get 11- and 12-year-olds to get the vaccine, we’ll make some progress,” said Geraldine McQuillan, an epidemiologist at the Centers for Disease Control and Prevention, and lead author of the new report.

“You need to give it before kids become sexually active, before they get infected,” Dr. McQuillan said. “By the time they’re in their mid-20s, people are infected and it’s too late. This is a vaccine against cancer — that’s the message.”

She and her colleagues also found that 7.3 percent of Americans ages 18 to 69 were infected orally with vHPV, and 4 percent were infected with the high-risk strains that can cause cancers of the mouth and pharynx.

HPV is a ubiquitous virus, the most common sexually transmitted infection in the United States. About 40 strains of the virus are sexually transmitted, and virtually all sexually active individuals are exposed to it by their early 20s.

The virus usually is spread through direct contact with infected genital skin or mucuous membranes during intercourse or oral sex. Over 90 percent of HPV infections are cleared by the body within two years. The figures released today were a snapshot of the prevalence of active oral HPV infection from 2011 through 2014, and active genital infection in 2013 and 2014.

Sometimes, the virus persists in the body. Chronic infections with certain strains can lead to genital warts and cancers of the cervix, vagina, penis, anus and throat. Two viral strains, HPV-16 and -18, cause almost all cervical cancers.

“One of the most striking things that we really want people to know is that high-risk HPV is common — common in the general population,” Dr. McQuillan said.

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While the C.D.C. recommends routine screening for cervical cancer for all women ages 21 to 65, adults are not routinely screened for HPV infection itself. Indeed, there is no HPV test for men at all. (A test for women is sometimes used in conjunction with a Pap screen for cervical cancer.)

There were significant differences in rates of high-risk genital HPV infection by race and ethnicity, Dr. McQuillan and her colleagues found.

The highest rate, 33.7 percent, was found among non-Hispanic blacks; the lowest, 11.9 percent, among Asians. The prevalence of genital HPV infection was 21.6 percent among whites and 21.7 percent among Hispanics.

Men generally have somewhat higher rates than women, but among Asian and Hispanic men, the infections are not significantly more common. The reasons for these variations are not known.

April, 2017|Oral Cancer News|

More than 1 In 5 Americans have a potentially cancer-causing HPV infection

Source: www.huffingtonpost.com
Author: Erin Schumaker

More than 42 percent of adults in the United States are infected with human papillomavirus ― and nearly 23 percent are infected with a high-risk strand of the virus that can cause cancer, according to a report published by the National Center for Health Statistics on Thursday.

“We tend to overlook the fact that 20 percent of us are carrying the virus that can cause cancer (indluding oral cancer – OCF news editor),” Geraldine McQuillan, lead author of the report and an epidemiologist at the U.S. Centers for Disease Control and Prevention, told The Washington Post.

“People really need to realize that this is a serious concern.”

The report, which examined U.S. adults ages 18 to 59, marks the first time the CDC has recorded HPV rates in men as well as women. There is no FDA-approved HPV test for men, but the CDC developed its own test for the research. “We did penile swabs which we tested for HPV DNA,” McQuillan told The Huffington Post.

HPV is the most common sexually transmitted disease in the country, and nearly every sexually active American will be exposed to it by their early 20s. Although 90 percent of HPV infections clear the body within two years, that’s not always the case. High-risk strains are linked to cervix, vaginal, penile, anus and throat cancers, as well as genital warts.

In fact, two high-risk strains, HPV-16 and -18, cause nearly all cervical cancer cases.

Not all Americans have the same risk of contracting high-risk HPV. Asian-Americans had the lowest HPV rate (12 percent), followed by whites and Hispanics (22 percent). Black Americans had the highest HPV prevalence (34 percent), according to the report. Overall, men were more likely to have high-risk genital HPV than women.

The best defense against HPV is getting the HPV vaccine before being exposed to the virus. The CDC strongly recommends the HPV vaccine as a cancer-prevention method for boys and girls starting at age 11, before they are exposed to the virus through sex.

“I commonly hear parents thinking that it’s better to wait until their children are sexually active before immunizing,” Dr. Dean Blumberg, associate professor and chief of pediatric infectious diseases at UC Davis Children’s Hospital, previously told The Huffington Post.

“Younger children have a more robust immune response to HPV vaccine compared to older children and young adults,” Blumberg said. “Specifically, children 9 to 15 years of age develop higher antibody levels after the vaccine series compared to 16- to 26-year-olds.”

While there’s no treatment for HPV itself (just for some symptoms, such as genital warts), routine Pap smears can catch cancer caused by the virus in its early stages. People with HPV should also use a condom to avoid passing the disease to a partner.

The CDC recommends cervical cancer screening for women ages 21 and older. The FDA approved an HPV test for women in 2003, but only 39 percent of clinicians ordered the test during a study of five Michigan health clinics from January 2008 to April 2011.

April, 2017|Oral Cancer News|

Eight updates in oral head and neck cancer

Source: www.healio.com
Author: staff

Oral Head and Neck Cancer Awareness Week — led by the Head and Neck Cancer Alliances and supported by the American Academy of Otolaryngology — raises awareness and promotes cancer screenings throughout the United States.

Approximately 110,000 people are diagnosed with oral head and neck cancers — which include cancers of the tongue, throat, voice box, nasal cavity, sinuses, lips, thyroid and salivary glands —each year in the United States.

“The best chance of effectively treating these cancers is early on in the disease, and that’s why identification of tumors in their earliest stage improves a patient’s likelihood of survival and the patient’s ability to speak and swallow normally after treatment,” Ilya Likhterov, MD, assistant professor of otolaryngology at Icahn School of Medicine at Mount Sinai, said in a press release from Mount Sinai. “While oral cancer is most commonly linked to long-time smokers and drinkers, younger patients can be affected even if they don’t have obvious risk factors. It is very important to have your mouth examined and pay attention to symptoms such as pain, bleeding, trouble swallowing, or if you notice any wound or ulcer in the mouth that is not healing quickly.”

In conjunction with Oral Head and Neck Cancer Awareness Week, HemOnc Today presents eight updates in oral head and neck cancer.

  • A combination of buparlisib (BKM120, Novartis) and paclitaxel may serve as an effective second-line therapy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Read more.
  • Nutrition plays a vital role during all phases of treatment for many cancer types, but it is particularly important for individuals with head and neck cancer, according to Jessica Iannotta, MS, RD, CSO, CDN, and Chelsey Wisotsky, MS, RD, CSO, CDN. Read more.
  • Roughly one in four men and one in five women in the United States have a high-risk form of HPV, according to CDC estimates. Read more.
  • Complete clinical response to induction chemotherapy may serve as a biomarker to identify patients with HPV–associated oropharyngeal squamous cell carcinoma who could benefit from radiation deintensification. Read more.
  • Patients with oral squamous cell carcinoma reported significant declines in the frequency of vaginal and oral sex after their diagnosis, regardless of tumor HPV status. Read more.
  • Adding cetuximab (Erbitux, Eli Lilly) to radiotherapy and cisplatin significantly improved PFS and OS in patients with KRAS-variant head and neck squamous cell carcinoma. Read more.
  • The American Cancer Society endorsed the updated recommendations from the Advisory Committee on Immunization Practices that support a two-dose schedule for boys and girls who initiate HPV vaccination from 9 to 14 years of age. Read more.
  • HPV is an increasingly important cause of oropharyngeal cancer not only among white men, but also among women and nonwhite individuals. HPV also causes a small proportion of nonoropharyngeal head and neck squamous cell cancer. Read more.
April, 2017|Oral Cancer News|

Unmasked, Cancer Survivors Face The Symbol Of Their Torture

Source: www.npr.org
Date: 09/28/2014
Author: Emily Siner

 

Every 15 minutes, for 10 hours a day, another patient walks into the radiation room at Vanderbilt-Ingram Cancer Center in Nashville. Each picks up a plastic mesh mask, walks to a machine, and lies down on the table underneath.

Nurses fit the mask over the patient’s face and shoulders. And then they snap it down.

“It was awful,” says Barbara Blades, who was diagnosed with cancer in her lymph nodes and tongue nine years ago. “It was awful to have your head bolted to a table. Not being able to move. Not being able to move your head.”

“I can remember lying there, thinking that I’m glad I’m not claustrophobic,” says Oscar Simmons, who had cancer in his tonsils.

“I sort of fibbed to myself,” says Bob Mead, who was diagnosed with salivary gland cancer in 2011. “I thought, if I had to, I could sit up and pull the mask off.”

Mead later realized he couldn’t have pulled up his mask. It’s designed to restrain his head so that the radiation targets the exact same spots — down to the millimeter — across several weeks.

The mask is made out of a kind of white plastic mesh that forms to a patient’s face. It’s see-through, but it looks almost human, like a ghostly person frozen in place.

Other survivors, like Steve Travis, who had tumors on his throat and neck and went through several weeks of radiation, say it felt comforting under the mask.

But when he finished treatment, Travis says, just thinking about the mask made him angry.

“Because it sort of represented everything that had happened for the last four months,” he says. “So I destroyed it.”

Cancer patient Troy Creasey lies under a radiation machine at Vanderbilt-Ingram Cancer Center. Radiation therapists snap the mask to the table to keep his head in place.

Emily Siner /NPR

Travis took it out to a family farm in West Tennessee and set it up next to a tree. He shot at it with two magazines from a .45 automatic — and then, for good measure, he burned it.

“I kept it for the longest time, and it just sat there,” says Barbara Blades, the woman with tongue cancer. “I couldn’t bring it myself to throw it away, because I had radiation five days a week for seven weeks. It was a part of me for that amount of time.”

Blades ended up keeping the radiation mask in her garage. She finally threw it out after it was damaged during a flood four years ago.

But Bob Mead, who had salivary gland cancer, held onto his mask with a sense of pride.

“It’s shaped like me. It fits me,” Mead says. “It’s like a favorite pair of jeans. People might not think of a mask that fondly, but there’s a familiarity to it. But the mask is actually part of me, and it’s that badge of honor that I have survived what is believed to have killed my cancer.”

Oscar Simmons, who had tonsil cancer, gave it to an artist who turned the mask into a sculpture of a mountain with a landscape around it as part of a project called Courage Unmasked, which has turned dozens of masks from survivors into art.

“Its goal is to restrain, and they’re going to expand,” Simmons says. “And so, it’s a thing of contrasts, I guess.”

As for Mead’s mask — he still hasn’t decided what to do with it.

“Mine’s actually sitting on my sun porch, on my shelf,” he says.

Every once in a while, he says he’ll pick it up and put it on his face. It still fits. And that’s OK, he says, because now, he’s free to take it off.

April, 2017|Oral Cancer News|

The scary reason doctors say kids need HPV vaccinations

Source: www.washingtonpost.com
Author: Sarah Vander Schaaff

When actor Michael Douglas told a reporter that his throat cancer was caused by HPV contracted through oral sex, two themes emerged that had nothing to do with celebrity gossip. The first was incredulity — since when was oral sex related to throat cancer? Even the reporter thought he had misheard. The second was embarrassment. This was too much information, not only about sexual behavior but also about one’s partners.

Douglas apologized, and maybe the world was not ready to hear the greater truth behind what he was suggesting.

That was four years ago.

Today, there is no doubt in the medical community that the increase in HPV-related cancers such as the one Douglas described — which he later explained was found at the base of his tongue — is caused by sexual practices, in his case cunnilingus. And there is an urgency to better treat and prevent what is becoming the one type of oral cancer whose numbers are climbing, especially among men in the prime of their lives who have decades to live with the consequences of their cancer treatment.

The number of people diagnosed with HPV-related oropharyngeal cancer, tumors found in the middle of the pharynx or throat including the back of the tongue, soft palate, sides of throat and tonsils — is relatively small — about 12,638 men and 3,100 women in the United States each year, according to the Centers for Disease Control and Prevention. But these numbers are expected to continue to rise, overtaking incidence of cervical cancer by 2020. One study revealed the presence of HPV in 20.9 percent of oropharyngeal tumors before 1990, compared with 65.4 percent in those sampled after 2000.

Alarming trend
It’s an alarming trend considering HPV, or human papilloma­virus, is the most common sexually transmitted infection in the country. The CDC estimates that nearly all sexually active men and women will get a form of the virus at some point. Although most HPV infections go away on their own, they are causing 30,700 cancers in men and women every year, including cervical, vaginal and penile cancers along with oral cancers.

Health agencies are pushing hard for HPV vaccinations, which they say could prevent most of those cancers. The CDC says all 11- and 12-year-olds should be ­vaccinated. And last year, the Food and Drug Administration approved a new two-dose series for children ages 9 to 14. And the American Academy of Pediatrics recently updated its vaccine recommendations to reflect that two-dose schedule, a reduction from the three shots previously required. (Children over 14 still need three shots.) The hope is to increase rates of completed vaccinations, which have lagged in the decade since the vaccines were released, averaging 42 percent for girls and 28 percent for boys, far below the Healthy People 2020 goal of 80­ percent.

The patients showing up in Ben Roman’s office at Memorial Sloan Kettering Cancer Center in New York, where he works as a head and neck surgeon and ­health-services researcher, came of age not only before these vaccines hit the market, but also before HPV and its link to cancers was fully understood. These cases, experts say, probably reflect several separate but interconnected factors: the sexual revolutions of the 1920s and 1960s that introduced more HPV into the general population, the changing sexual practices of young people who report more histories of oral sex, and that it can take 10 to 30 years for tumors to develop after an infection.

Roman has seen an increase in a new type of head and neck cancer patient. They are typically white, middle-aged men, ­otherwise healthy, who have no history of smoking or drinking. They may have first noticed a mass in their necks or lymph nodes while buttoning a shirt or shaving. An ear, nose and throat doctor has determined the primary source of the cancer: the tonsils or base of the tongue.

“Most people are familiar with tonsils in the back of the throat,” Maura Gillison, a leading expert in HPV-related cancers at the ­University of Texas MD Anderson Cancer Center, said. “But we also have them in the base of the tongue.”

The palatine tonsils are on the sides of the throat, and there are also lingual tonsils on the back of the tongue. Both areas are made of the same lymphoid tissue at particular risk for HPV infection, and are part of what specialists call Waldeyer’s Ring.

Experts are not sure why an HPV infection in the tonsils is more likely to lead to cancer. It could be because of their anatomy, which has crypts and crevices, making it harder to clear an infection. Gillison said it could also be because of where the tonsils are in the body, an area that serves as a transition from the outside to the inside, much like the genital tract and cervix.

German researcher Harald zur Hausen identified the types of HPV that cause cervical cancer 34 years ago, work that earned him the Nobel Prize in 2008 and contributed to the development of the HPV vaccine. One of those types, HPV-16, is identified in more than half of cancers in the oropharynx, according to the National Cancer Institute.

But there are important distinctions between men and women when it comes to HPV-related cancers. Cervical cancer deaths, for example, have been greatly reduced through early detection with the use of Pap smears. The same screening for precursor lesions or pre-cancer is not yet possible for the oropharyngeal cancers, commonly referred to as OPC or OSCC, for oropharyngeal squamous cell carcinomas.

The male risk
Another difference is how men and women respond to infection. The majority of women develop antibodies to clear HPV when exposed vaginally. These antibodies remain in the body so that a woman is protected from a subsequent oral infection. Men, in contrast, are much less likely to develop antibodies after genital exposure to the virus. When tested, their titers — a measurement of antibodies — are lower, leaving them five times more likely than women to have an oral infection.

HPV is considered an unusual virus because it does not travel through the bloodstream. Infection is localized, meaning it stays at the place where contact occurs. In tonsil cancer, then, oral sex becomes a relevant risk factor, so significant that in an article in the Journal of Clinical Oncology, Gillison and her colleagues stated that the number of these oral sex partners in a lifetime is the behavior measure that is, “. . . most strongly, consistently, and specifically associated with OPC (tonsil and base of tongue).”

Treating a cancer related to a sexually transmitted infection brings up sensitive questions. Roman said a patient’s spouse will often pull him aside to ask: “When did he get this? Was he cheating?” He suggests the patient was probably exposed years ago. But from the viewpoint of prognosis, the HPV-related cancers respond better to treatment.

That fact has prompted rapid changes in treatment protocols that were as recently as five years ago based on heavy smoking and drinking. These new strategies back down from the aggressive radiation, chemotherapy and surgery that exposed patients to high toxicity and could damage the ability to speak and swallow.

When Gillison started her research in 2000, there was little awareness that sexual behavior contributed to cancer of the throat, and fellow researchers were skeptical.

“People were laughing. They thought it was absurd,” she said. Now, Gillison is credited with formally putting together the behavioral data and biomarkers to quell any skepticism, Carole Fakhry, an associate professor of otolaryngology and surgeon at Johns ­Hopkins, said.

Others had noted HPV in oral cavity cancer, but no one was sure whether it was a fluke or more significant. So Gillison reviewed tumor specimens collected by a colleague and then set out to study all of the available ­literature, presenting an analysis in 2009 that compared the ­survival rates of those with HPV-positive and -negative oropharynx cancers. Gillison describes her work — a confluence of observations in the lab and clinic — as an act of serendipity.

“I have always been interested in the association between ­infectious diseases and tumors because there are so many ­opportunities to intervene. If an infection causes a cancer, you can try to prevent infection in the first place, or screen, or if it’s developed you can use the fact that it’s associated with a virus — you can treat cancer by treating infection.”

As far as vaccination’s effect on preventing OPC in men, data is still under review. Officially, the vaccine is recommended for boys and young men to prevent genital warts and anal pre-cancers. But those focused on pediatrics, such as Margaret Stager, director of adolescent medicine at MetroHealth medical center in Ohio and an official spokeswoman for the American Academy of Pediatrics, say that HPV vaccination clearly decreases spreading of HPV through the community, offering immediate, midrange and long-term benefits. And the current vaccines do protect against HPV-16, one of the high-risk types of the virus found in both cervical cancer and a majority of OPC.

New, easier vaccine
The new two-dose vaccination is designed to reach children when their antibody response is highest and make completion less cumbersome, as are electronic medical records that cue physicians when a vaccine is due. The District of Columbia is one of the few areas that has made the vaccine a required immunization for students in grades six through 12, although families may opt out.

There is still a gap in knowledge among some general ­practitioners and dentists, according to Gillison.

It is not uncommon for her to hear a story from a patient who comes to her after six months or so after going to his doctor.

“He told me not to worry ­because I was fighting off an infection. He gave me antibiotics. They were not working. Then ­another lump occurred next to that one . . . ”

The patient is young, healthy and doesn’t smoke. He has a sore throat and a neck mass that doesn’t respond to antibiotics.

Those in the front lines of ­medical practice, she said, should have in mind the question: Could this patient have head and neck cancer?

April, 2017|Oral Cancer News|